April 15, 2022
New Cybersecurity Guidance from the FDA
The Food and Drug Administration (FDA) has released draft guidance on cybersecurity for medical devices. The guidance is meant to provide recommendations to industry regarding cybersecurity device design, labeling and the documentation that the FDA recommends be included in premarket submissions. The need for effective cybersecurity to ensure medical device safety has become more important with the increasing use of wireless, Internet- and network-connected devices. In addition, cybersecurity threats to the health care sector have become more frequent, more severe and more clinically impactful.